Transitioning Young Patients' Health Care Trajectories

Child, Only Clinical Trial

Official title:

Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04652154
• Other study ID #: 2018/344
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services.

In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes:

• To implement the new team intervention in a clinical case-control study

• To scientifically evaluate the intervention

• To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.

Description:

200 children with multi-referrals will be invited to either intervention or treatment as usual at their third or more referral to Haukeland university hospital.

In the intervention group the child and family will meet a complementary team of professionals for more than two hours aimimg to get a clarification of the patient's condition and giving coping strategies for their condition. Outcome defined as better mental health and quality of life as well as increased school attendence are some of the measures being collected. These outcomes will be compared to the control group after 12 mth.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Age 6-16 years,

• Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.

Exclusion Criteria:

• Not within age range

• Less than 3 referrals

Related Conditions & MeSH terms

• Child, Only
• Health Care Utilization
• Mental Health Impairment
• Multi-morbidity

Intervention

Other:
• Transitioning young patients' health care trajectories
New intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child

Locations

Country	Name	City	State
Norway	Haukeland universitet sykehus	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Elgen I, Heggestad T, Tronstad R, Greve G. Bridging the Gap for Children With Compound Health Challenges: An Intervention Protocol. Front Pediatr. 2021 Dec 22;9:721926. doi: 10.3389/fped.2021.721926. eCollection 2021. — View Citation

Elgen I, Lygre R, Greve G, Griffiths S, Heggestad T. Interdisciplinary Approaches Suggested for Children With Multiple Hospital Referrals Presenting With Non-specific Conditions. Front Pediatr. 2021 Apr 7;9:656939. doi: 10.3389/fped.2021.656939. eCollecti — View Citation

Elgen I, Lygre RB, Arli A, Heggestad T. An interdisciplinary intervention for children with complex health complaints; a feasibility study of selection criteria. Front Pediatr. 2023 Sep 14;11:1167528. doi: 10.3389/fped.2023.1167528. eCollection 2023. — View Citation

Heggestad T, Greve G, Skilbrei B, Elgen I. Complex care pathways for children with multiple referrals demonstrated in a retrospective population-based study. Acta Paediatr. 2020 Dec;109(12):2641-2647. doi: 10.1111/apa.15250. Epub 2020 Apr 17. — View Citation

Lygre RB, Gjestad R, Norekval TM, Mercer SW, Elgen IB. An interdisciplinary intervention for children and adolescents with multiple referrals and complex health complaints: a feasibility study. BMC Health Serv Res. 2023 Nov 11;23(1):1241. doi: 10.1186/s12 — View Citation

Lygre RB, Thuen VM, Gjestad R, Norekval TM, Greve G, Mildestvedt T, Elgen IB. How can we improve specialist health services for children with multi-referrals? Parent reported experience. BMC Health Serv Res. 2020 Aug 24;20(1):786. doi: 10.1186/s12913-020- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contentment with the intervention - Patient	Patient evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Patient)" with two items and for each item has a score 1-4 and 4 is most positive.	Through study completion, an average of 2 years
Primary	Contentment with the intervention - Parents	Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.	Baseline
Primary	Contentment with the intervention - Parents	Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.	Through study completion, an average of 2 years
Primary	Contentment with the intervention - Professionals	Professionals evaluate the intervention - A questionnaire for the study has been developed Usefulness of the TpT intervention with two items and score for each item has 1-4 and 4 is most positive.	Through study completion, an average of 2 years
Primary	Mental health status	Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.	Baseline
Primary	Mental health status	Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.	1 year after the intervention
Primary	Mental health status	Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.	2 year after the intervention
Primary	Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år	Using KIDSCREEN-27 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items).; Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.	Baseline
Primary	Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år	Using KIDSCREEN-10 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items).; Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.	1 year after the intervention
Secondary	Contact with specialist healthcare	Post evaluation of use of health services - numbers of new referrals	1 year after the intervention after the intervention